Combination Chemotherapy in Treating Patients With Early Stage Breast Cancer That Has Been Removed By Surgery (TACT2)

Trial of Accelerated Adjuvant Chemotherapy With Capecitabine in Early Breast Cancer (TACT2)

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy after surgery may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating early stage breast cancer that has been removed by surgery.

PURPOSE: This randomized phase III trial is studying four different combination chemotherapy regimens to compare how well they work in treating patients with early stage breast cancer that has been removed by surgery.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: cyclophosphamide; Drug: fluorouracil; Drug: methotrexate; Procedure: adjuvant therapy; Drug: capecitabine; Drug: epirubicin hydrochloride; Biological: pegfilgrastim

Detailed Description

OBJECTIVES:

Primary

• Compare the disease-free survival (DFS) of patients with completely resected early stage breast cancer receiving 1 of 2 different schedules of adjuvant chemotherapy comprising epirubicin, cyclophosphamide, methotrexate, and fluorouracil versus 1 of 2 different schedules of adjuvant chemotherapy comprising epirubicin and capecitabine.

Secondary

• Compare overall survival (OS) and distant disease-free survival (DFS).
• Compare the tolerability (including serious adverse events [SAE], dose-intensity, and toxicity) of these regimens.
• Determine the detailed toxicity of these regimens.
• Determine the quality of life of a subset of these patients.

OUTLINE: This is a multi-center, randomized study. Patients are stratified according to participating center, nodal status (N0 vs N1-3 vs N≥ 4), age (≤ 50 years vs > 50 years), and estrogen receptor (ER) status (negative vs positive). Patients are randomized to 1 of 4 treatment arms.

• Arm I: Patients receive epirubicin on day 1. Treatment repeats every 3 weeks for 4 courses. Patients then receive cyclophosphamide orally once daily on days 1-14 or IV on days 1 and 8 and methotrexate and fluorouracil on days 1 and 8. Treatment repeats every 28 days for 4 courses.
• Arm II: Patients receive epirubicin on day 1 and pegfilgrastim on day 2. Treatment repeats every 2 weeks for 4 courses. Patients then receive cyclophosphamide, methotrexate and fluorouracil as in arm I.
• Arm III: Patients receive epirubicin as in arm I. Patients then receive oral capecitabine twice daily on days 1-14. Treatment with capecitabine repeats every 3 weeks for 4 courses.
• Arm IV: Patients receive epirubicin and pegfilgrastim as in arm II. Patients then receive capecitabine as in arm III.

In all arms, treatment continues in the absence of unacceptable toxicity.

Beginning 3-6 months later, all patients may undergo radiotherapy at the discretion of the principal investigator. Patients with ER- and/or progesterone receptor-positive disease then receive tamoxifen citrate or an aromatase inhibitor for up to 5 years.

Quality of life is assessed in a cohort of 1,000 patients in week 6, week 8 or 12, and week 20 or 24 during treatment and then at 12 and 24 months after randomization.

After completion of study therapy, patients are followed every 6 months for 2 years and then annually for at least 10 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

PROJECTED ACCRUAL: A total of 4,400 patients will be accrued for this study.

• Study Type: Interventional
• Enrollment (Anticipated): 4400
• Phase: Phase 3

Contacts and Locations

Study Locations

• United Kingdom
  • Barnet, Hertfordshire, United Kingdom, EN5 3DJ
    • Barnet General Hospital
  • England
    • Ashford-Kent, England, United Kingdom, TN24 0LZ
      • William Harvey Hospital
    • Ashington, England, United Kingdom, NE63 9JJ
      • Wansbeck General Hospital
    • Ashton-Under-Lyne, England, United Kingdom, OL6 9RW
      • Tameside General Hospital
    • Barnstaple, England, United Kingdom, EX31 4JB
      • North Devon District Hospital
    • Barrow in Furness, England, United Kingdom, LA14 4LF
      • Furness General Hospital
    • Basildon, England, United Kingdom, SS16 5NL
      • Basildon University Hospital
    • Basingstoke, England, United Kingdom, RG24 9NA
      • Basingstoke and North Hampshire NHS Foundation Trust
    • Birmingham, England, United Kingdom, B18 7QH
      • City Hospital - Birmingham
    • Birmingham, England, United Kingdom, B9 5SS
      • Birmingham Heartlands Hospital
    • Birmingham, England, United Kingdom, B15 2TH
      • Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
    • Blackburn, England, United Kingdom, BB2 3HH
      • Royal Blackburn Hospital
    • Blackpool, England, United Kingdom, FY3 8NR
      • Blackpool Victoria Hospital
    • Bolton, Lancashire, England, United Kingdom, BL4 0JR
      • Royal Bolton Hospital
    • Bradford, England, United Kingdom, BD9 6RJ
      • Bradford Royal Infirmary
    • Brighton, England, United Kingdom, BN2 5BF
      • Sussex Cancer Centre at Royal Sussex County Hospital
    • Bristol, England, United Kingdom, BS2 8ED
      • Bristol Haematology and Oncology centre
    • Broomefield, England, United Kingdom, CM1 7ET
      • Broomfield Hospital
    • Burnley, England, United Kingdom, BB10 2PQ
      • Burnley General Hospital
    • Burton-upon-Trent, England, United Kingdom, DE13 0RB
      • Queen's Hospital
    • Bury St. Edmunds, England, United Kingdom, IP33 2QZ
      • West Suffolk Hospital
    • Cambridge, England, United Kingdom, CB2 2QQ
      • Addenbrooke's Hospital
    • Canterbury, England, United Kingdom, CT2 3NG
      • Kent and Canterbury Hospital
    • Cheltenham, England, United Kingdom, GL53 7AN
      • Cheltenham General Hospital
    • Cheshire, England, United Kingdom, WA7 2DA
      • Halton Hospital
    • Chesterfield, England, United Kingdom, S44 5BL
      • Chesterfield Royal Hospital
    • Chichester, England, United Kingdom, P019 4SE
      • Saint Richards Hospital
    • Colchester, England, United Kingdom, C03 3NB
      • Essex County Hospital
    • Coventry, England, United Kingdom, CV2 2DX
      • Walsgrave Hospital
    • Dartford Kent, England, United Kingdom, DA2 8DA
      • Darent Valley Hospital
    • Derby, England, United Kingdom, DE1 2QY
      • Derbyshire Royal Infirmary
    • Dewsbury, England, United Kingdom, WF13 4HS
      • Dewsbury and District Hospital
    • Doncaster, England, United Kingdom, DN2 5LT
      • Doncaster Royal Infirmary
    • Dudley, England, United Kingdom, DY1 2HQ
      • Russells Hall Hospital
    • Durham, England, United Kingdom, DH1 5TW
      • University Hospital of North Durham
    • Eastbourne, England, United Kingdom, BN21 2UD
      • Eastbourne District General Hospital
    • Exeter, England, United Kingdom, EX2 5DW
      • Royal Devon and Exeter Hospital
    • Gateshead, England, United Kingdom, NE9 6SX
      • Queen Elizabeth Hospital
    • Gloucester, England, United Kingdom, GL1 3NN
      • Gloucestershire Royal Hospital
    • Grimsby, England, United Kingdom, DN33 2BA
      • Diana Princess of Wales Hospital
    • Guildford, England, United Kingdom, GU2 7XX
      • St. Luke's Cancer Centre at Royal Surrey County Hospital
    • Hampstead, London, England, United Kingdom, NW3 2QG
      • UCL Cancer Institute
    • Hereford, England, United Kingdom, HR1 2ER
      • Hereford Hospitals NHS Trust
    • High Wycombe, England, United Kingdom
      • Wycombe General Hospital
    • Huddersfield, West Yorks, England, United Kingdom, HD3 3EA
      • Huddersfield Royal Infirmary
    • Hull, England, United Kingdom, HU8 9HE
      • Princess Royal Hospital at Hull and East Yorkshire NHS Trust
    • Ilford, Essex, England, United Kingdom, IG3 8YB
      • King George Hospital
    • Ipswich, England, United Kingdom, IP4 5PD
      • Ipswich Hospital
    • Isleworth, England, United Kingdom, TW7 6AF
      • West Middlesex University Hospital
    • Keighley, England, United Kingdom, BD20 6TD
      • Airedale General Hospital
    • Kettering, Northants, England, United Kingdom, NNI6 8UZ
      • Kettering General Hosptial
    • Kidderminster Worcestershire, England, United Kingdom, DY11 6RJ
      • Kidderminster Hospital
    • King's Lynn, England, United Kingdom, PE30 4ET
      • Queen Elizabeth Hospital
    • Lancanshire, England, United Kingdom, WN1 2NN
      • Royal Albert Edward Infirmary
    • Lancaster, England, United Kingdom, LA1 4RP
      • Royal Lancaster Infirmary
    • Leeds, England, United Kingdom, LS9 7TF
      • Leeds Cancer Centre at St. James's University Hospital
    • Leeds, England, United Kingdom, LS16 6QB
      • Cookridge Hospital
    • Leeds, England, United Kingdom, LS2 9LN
      • National Cancer Research Network
    • Leeds, England, United Kingdom, LS9 7TF
      • Cancer Research UK Clinical Centre at St. James's University Hospital
    • Liverpool, England, United Kingdom, L9 7AL
      • Aintree University Hospital
    • Liverpool, England, United Kingdom, L7 8XP
      • Royal Liverpool University Hospital
    • London, England, United Kingdom, EC1M 6BQ
      • Barts and the London School of Medicine
    • London, England, United Kingdom, SW17 0QT
      • St. George's Hospital
    • London, England, United Kingdom, W6 8RF
      • Charing Cross Hospital
    • London, England, United Kingdom, W2 1NY
      • St. Mary's Hospital
    • London, England, United Kingdom, SE5 9RS
      • King's College Hospital
    • London, England, United Kingdom, SE1 9RT
      • Guy's Hospital
    • London, England, United Kingdom, N19 5NF
      • Whittington Hospital
    • London, England, United Kingdom, NW1 2BU
      • University College Hospital
    • Macclesfield, England, United Kingdom, SK10 3BL
      • Macclesfield District General Hospital
    • Maidstone, England, United Kingdom, ME16 9QQ
      • Maidstone Hospital
    • Manchester, England, United Kingdom, M20 4BX
      • Christie Hospital
    • Manchester, England, United Kingdom, M20 8LR
      • Withington Hospital
    • Manchester, England, United Kingdom, M8 6RB
      • North Manchester General Hospital - Penine Actute Hospitals Trust
    • Margate, England, United Kingdom, CT9 4AN
      • Queen Elizabeth the Queen Mother Hospital
    • Merseyside, England, United Kingdom, CH63 4JY
      • Clatterbridge Centre for Oncology
    • Middlesbrough, England, United Kingdom, TS4 3BW
      • James Cook University Hospital
    • Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE
      • Northern Centre for Cancer Treatment at Newcastle General Hospital
    • Newport, England, United Kingdom, PO30 5TG
      • St. Mary's Hospital
    • Norfolk, England, United Kingdom, NR31 6LA
      • James Paget Hospital
    • North Shields, England, United Kingdom, NE29 8NH
      • North Tyneside Hospital
    • North Yorkshire, England, United Kingdom, DL6 1JG
      • Friarage Hospital
    • Northampton, England, United Kingdom, NN6 8BJ
      • Northampton General Hospital NHS Trust
    • Norwich, England, United Kingdom, NR4 7UY
      • Norfolk and Norwich University Hospital
    • Nottingham, England, United Kingdom, NG5 1PB
      • Nottingham City Hospital NHS Trust
    • Nottinghamshire, England, United Kingdom, NG17 4JL
      • King's Mills Hospital
    • Nuneaton, England, United Kingdom, CV10 7DJ
      • George Eliot Hospital
    • Oldham, England, United Kingdom, OL1 2JH
      • Royal Oldham Hospital
    • Oxford, England, United Kingdom, OX3 7LJ
      • Churchill Hospital
    • Oxford, England, United Kingdom, OX2 6HE
      • Radcliffe Infirmary NHS Trust
    • Peterborough, England, United Kingdom, PE3 6DA
      • Peterborough Hospitals Trust
    • Pontefract West Yorkshire, England, United Kingdom, WF8 1PL
      • Pontefract General Infirmary
    • Prescot Merseyside, England, United Kingdom, L35 5DR
      • Whiston Hospital
    • Preston, England, United Kingdom, PR2 4QF
      • Royal Preston Hospital
    • Redditch, Worcestershire, England, United Kingdom, B98 7UB
      • Alexandra Healthcare NHS
    • Romford, England, United Kingdom, RM7 OBE
      • Oldchurch Hospital
    • Saint Leonards-on-Sea, England, United Kingdom, TN37 7RD
      • Conquest Hospital
    • Salisbury, England, United Kingdom, SP2 8BJ
      • Salisbury District Hospital
    • Scunthorpe, England, United Kingdom, DN15 7BH
      • Scunthorpe General Hospital
    • Sheffield, England, United Kingdom, S1O 2SJ
      • Cancer Research Centre at Weston Park Hospital
    • Shrewsbury, England, United Kingdom, SY3 8XQ
      • Royal Shrewsbury Hospital
    • Solihull, England, United Kingdom, B91 2JL
      • Solihull Hospital
    • Southampton, England, United Kingdom, SO16 6YD
      • Southampton General Hospital
    • Southport, England, United Kingdom, PR8 6PN
      • Southport and Formby District General Hospital
    • Stockport, England, United Kingdom, SK2 7JE
      • Stepping Hill Hospital
    • Stoke-On-Trent, England, United Kingdom, ST4 7LN
      • University Hospital of North Staffordshire
    • Sunderland, England, United Kingdom, SR4 7TP
      • Sunderland Royal Hospital
    • Swindon, England, United Kingdom, SN3 6BB
      • Great Western Hospital
    • Taunton, England, United Kingdom, TA1 5DA
      • Taunton and Somerset Hospital
    • Torquay, England, United Kingdom, TQ2 7AA
      • Torbay Hospital
    • Truro, Cornwall, England, United Kingdom, TR1 3LJ
      • Royal Cornwall Hospital
    • Walsall, England, United Kingdom, WS2 9PS
      • Walsall Manor Hospital
    • Warrington, England, United Kingdom, WA5 1QG
      • Warrington Hospital NHS Trust
    • Warwick, Warwickshire, England, United Kingdom, CV34 5BJ
      • South Warwickshire Hospital
    • West Bromwich, England, United Kingdom, B71 4HJ
      • Sandwell General Hospital
    • Westcliff-On-Sea, England, United Kingdom, SS0 0RY
      • Southend University Hospital NHS Foundation Trust
    • Weston-super-Mare, England, United Kingdom, BS23 4TQ
      • Weston General Hospital
    • Winchester, England, United Kingdom, SO22 5DG
      • Royal Hampshire County Hospital
    • Wolverhampton, England, United Kingdom, WV10 0QP
      • New Cross Hospital
    • Worcester, England, United Kingdom, WR5 1DD
      • Worcester Royal Hospital
    • Yeovil - Somerset, England, United Kingdom, BA21 4AT
      • Yeovil District Hospital
  • Northern Ireland
    • Belfast, Northern Ireland, United Kingdom, BT8 8JR
      • Belfast City Hospital Trust Incorporating Belvoir Park Hospital
    • Belfast, Northern Ireland, United Kingdom, BT9 7AB
      • Centre for Cancer Research and Cell Biology at Queen's University Belfast
    • Londonderry, Northern Ireland, United Kingdom, BT47 1SB
      • Altnagelvin Area Hospital
  • Scotland
    • Aberdeen, Scotland, United Kingdom, AB25 2ZN
      • Aberdeen Royal Infirmary
    • Ayr, Scotland, United Kingdom, KA6 6DX
      • Ayr Hospital
    • Dumfries, Scotland, United Kingdom, DG1 4AP
      • Dumfries & Galloway Royal Infirmary
    • Dundee, Scotland, United Kingdom, DD1 9SY
      • Ninewells Hospital
    • Dunfermline, Scotland, United Kingdom, KY12 0SU
      • Queen Margaret Hospital - Dunfermline
    • East Kilbride, Scotland, United Kingdom, G75 8RG
      • Hairmyres Hospital
    • Edinburgh, Scotland, United Kingdom, EH4 2XU
      • Edinburgh Cancer Centre at Western General Hospital
    • Elgin, Scotland, United Kingdom, IV30 1SN
      • Dr Gray's Hospital
    • Falkirk, Scotland, United Kingdom, FK1 5QE
      • Falkirk & District Royal Infirmary
    • Glasgow, Scotland, United Kingdom, G4 0SF
      • Royal Infirmary - Castle
    • Glasgow, Scotland, United Kingdom, G11 6NT
      • Beatson West of Scotland Cancer Centre
    • Greenock, Scotland, United Kingdom, PA16 0XN
      • Inverclyde Royal Hospital
    • Inverness, Scotland, United Kingdom, 1V2 3UJ
      • Raigmore Hospital
    • Kilmarnock, Scotland, United Kingdom, KA2 OBE
      • Crosshouse Hospital
    • Livingston, Scotland, United Kingdom, EH54 6PP
      • St. John's Hospital
    • Scarborough, Scotland, United Kingdom, YO12 6QL
      • Scarborough General Hospital
    • Wakefield, Scotland, United Kingdom, WF1 4DG
      • Pinderfields General Hospital
    • Wishaw, Scotland, United Kingdom, ML2 0DP
      • Wishaw General Hospital
  • Wales
    • Aberystwyth, Wales, United Kingdom, SY23 1ER
      • Bronglais District General Hospital
    • Bangor, Wales, United Kingdom, LL57 2PW
      • Ysbyty Gwynedd
    • Bridgend, Wales, United Kingdom, CF31 1JP
      • Princess of Wales Hospital
    • Cardiff, Wales, United Kingdom, CF14 2TL
      • Velindre Cancer Center at Velindre Hospital
    • Haverfordwest, Wales, United Kingdom, SA61 2PZ
      • Withybush General Hospital
    • Lhantrisant, Wales, United Kingdom, CF72 8XR
      • Royal Glamorgan Hospital
    • Mid Glamorgan, Wales, United Kingdom, CF47 9DT
      • Prince Charles Hospital
    • Newport Gwent, Wales, United Kingdom, NP9 2UB
      • Royal Gwent Hospital
    • Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ
      • Glan Clwyd Hospital
    • Wrexham, Wales, United Kingdom, LL13 7NT
      • Wrexham Maelor Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

DISEASE CHARACTERISTICS:

• Histological diagnosis of invasive breast carcinoma

  • Cytological proof of malignancy alone is not sufficient
  • Early stage disease (T0-3, N0-2, M0) without clinical suspicion or evidence of distant metastases on routine staging
  • No locally advanced breast cancer (T4 and/or N3 disease)

• Completely resected disease by breast-conserving surgery with axillary node clearance or modified radical mastectomy within the past 4-8 weeks

  • Negative surgical margins required, unless either of the following are true:

    • Deep surgical margins after full thickness resection
    • Noninvasive cancer at surgical margins for which a mastectomy is planned after completion of study chemotherapy
  • No contraindication for or refusal of postoperative radiotherapy in patients who underwent prior breast-conserving surgery
• Definite indication for adjuvant chemotherapy

• No prior or current invasive breast cancer or bilateral breast cancer

  • Prior surgically-treated ductal carcinoma in situ or lobular carcinoma in situ allowed

• Hormone receptor status:

  • Estrogen receptor- and/or progesterone receptor-positive or -negative tumor

PATIENT CHARACTERISTICS:

• Sex: male or female
• Menopausal status: premenopausal or postmenopausal
• No previous malignancy except basal cell carcinoma, carcinoma in situ of the cervix, or any cancer from which the patient has been disease-free for 10 years and for which treatment consisted solely of resection
• ECOG status 0 or 1
• Hemoglobin > 9 g/dL
• WBC > 3,000/mm³
• Platelet count > 10,000/mm³
• Bilirubin normal (unless due to known Gilbert's disease)
• AST and ALT ≤ 1.5 times upper limit of normal (ULN)
• Albumin normal
• Creatinine ≤ 1.5 times ULN
• Creatinine clearance > 50 mL/min
• No active, uncontrolled infection
• Not pregnant or nursing
• Fertile patients must use effective contraception
• No concurrent medical, psychiatric, or geographic problems that might prevent completion of treatment or follow-up
• Available for a minimum of 5 years' follow-up
• No known serious viral infection such as active hepatitis B, hepatitis C, or HIV
• No significant cardiac disease, such as impaired left ventricular function or active angina requiring regular anti-anginal medication and/or resulting in restricted physical activity
• No history of significant renal impairment or disease

PRIOR CONCURRENT THERAPY:

• No simultaneous participation in the active intervention phase of another treatment trial
• Not being approached or recruited for another trial within 2 months of study entry

• No previous chemotherapy, hormonal therapy or radiotherapy for the treatment of pre-invasive or invasive cancer except for either of the following:

  • Previous radiotherapy for basal cell carcinoma
  • Previous preoperative endocrine therapy, provided there was no evidence of progression during this therapy, it lasted for less than 6 weeks in duration, and it was stopped at least one month prior to trial entry
• Concurrent luteinizing hormone-releasing hormone analog therapy allowed for premenopausal patients
• More than 4 weeks since prior hormone replacement therapy (HRT) or pre-operative endocrine therapy
• No prior breast conserving surgery if there is a contradiction for or refusal of postoperative radiotherapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Epi-CMF	Drug: cyclophosphamide; Drug: fluorouracil; Drug: methotrexate; Procedure: adjuvant therapy; Drug: epirubicin hydrochloride
Experimental: Accelerated Epi-CMF	Drug: cyclophosphamide; Drug: fluorouracil; Drug: methotrexate; Procedure: adjuvant therapy; Drug: epirubicin hydrochloride; Biological: pegfilgrastim
Experimental: Epi-Capecitabine	Procedure: adjuvant therapy; Drug: capecitabine; Drug: epirubicin hydrochloride
Experimental: Accelerated Epi-Capecitabine	Procedure: adjuvant therapy; Drug: capecitabine; Drug: epirubicin hydrochloride; Biological: pegfilgrastim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Disease-free survival (DFS) at 5 years

Secondary Outcome Measures

Outcome Measure
Quality of life
Overall survival at 5 years
Distant DFS at 5 years
Tolerability (including serious adverse events, dose-intensity, and toxicity)
Detailed toxicity

Collaborators and Investigators

• Sponsor: Institute of Cancer Research, United Kingdom
• Investigators: Study Chair: David Cameron, MD, National Cancer Research Network

Publications and helpful links

General Publications

• Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
• Cameron D, Morden JP, Canney P, Velikova G, Coleman R, Bartlett J, Agrawal R, Banerji J, Bertelli G, Bloomfield D, Brunt AM, Earl H, Ellis P, Gaunt C, Gillman A, Hearfield N, Laing R, Murray N, Couper N, Stein RC, Verrill M, Wardley A, Barrett-Lee P, Bliss JM; TACT2 Investigators. Accelerated versus standard epirubicin followed by cyclophosphamide, methotrexate, and fluorouracil or capecitabine as adjuvant therapy for breast cancer in the randomised UK TACT2 trial (CRUK/05/19): a multicentre, phase 3, open-label, randomised, controlled trial. Lancet Oncol. 2017 Jul;18(7):929-945. doi: 10.1016/S1470-2045(17)30404-7. Epub 2017 Jun 7.

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2005
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: March 9, 2006
• First Submitted That Met QC Criteria: March 9, 2006
• First Posted (Estimate): March 13, 2006

Study Record Updates

• Last Update Posted (Actual): August 8, 2018
• Last Update Submitted That Met QC Criteria: August 7, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: stage IIIA breast cancer; male breast cancer; stage II breast cancer; stage I breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Dermatologic Agents; Antibiotics, Antineoplastic; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Cyclophosphamide; Fluorouracil; Capecitabine; Epirubicin; Methotrexate
• Other Study ID Numbers: CDR0000463447; ICR-TACT2; EU-205114; EUDRACT-2004-000066-13; MREC-04/MRE00/88; ISRCTN68068041